Claims for Patent: 12,263,146

Summary for Patent: 12,263,146

Title:	Non-linear dosing of mirdametinib
Abstract:	The present disclosure relates to methods for treating certain types of tumors or cancers, such as plexiform neurofibromas (PN), plexiform neurofibromas associated with neurofibromatosis type 1 (NF1-PN), by administering to a patient in need thereof mirdametinib or a pharmaceutically acceptable salt thereof, such as by a certain dosing scheme.
Inventor(s):	Uchenna H. Iloeje, Abraham J. Langseth, Todd Shearer
Assignee:	SpringWorks Therapeutics Inc
Application Number:	US18/364,058
Patent Claims:	1. A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) and a body surface area of 1.5 to 1.74 m2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 4 mg mirdametinib twice daily. 2. The method of claim 1, wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis. 3. The method of claim 2, wherein in step (i), mirdametinib is selected based on a response rate of at least 70%. 4. A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) and a body surface area of no more than 0.69 m2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 1 mg mirdametinib. 5. The method of claim 4, wherein the patient is administered 1 mg mirdametinib twice daily. 6. The method of claim 4, wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis. 7. The method of claim 6, wherein in step (i), mirdametinib is selected based on a response rate of at least 70%. 8. A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) and a body surface area of 0.7 to 1.04 m2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 2 mg mirdametinib. 9. The method of claim 8, wherein the patient is administered 2 mg mirdametinib twice daily. 10. The method of claim 8, wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis. 11. The method of claim 10, wherein in step (i), mirdametinib is selected based on a response rate of at least 70%. 12. A method of treating a human patient 2 years or older who has neurofibromatosis type 1 (NF1) associated inoperable plexiform neurofibromas (PN) and a body surface area of 1.05 to 1.49 m2 comprising orally administering an effective amount of mirdametinib to the patient, wherein the patient is initially administered 3 mg mirdametinib. 13. The method of claim 12, wherein the patient is administered 3 mg mirdametinib twice daily. 14. The method of claim 12, wherein the method further comprises prior to treatment (i) determining whether to select mirdametinib as a treatment for the patient, and (ii) selecting mirdametinib as a treatment for the patient at least partially based on its objective response rate, where the objective response rate is defined as at least a 20% decrease in tumor size using centrally read MRI volumetric analysis. 15. The method of claim 14, wherein in step (i), mirdametinib is selected based on a response rate of at least 70%.